BENZTROPINE MESYLATE

Product NDC: 76385-105
11-digit product format: 763850105
Labeler code: 76385
Product ID: 76385-105_6b06c066-bc21-402d-a499-547e5f8339c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BENZTROPINE MESYLATE
Dosage form: TABLET
Route: ORAL
Labeler: Bayshore Pharmaceuticals LLC (NJ)
Application: ANDA090168
Marketing category: ANDA
Marketing start: 2014-01-31
Marketing end: 0000-00-00
Substance: BENZTROPINE MESYLATE
Active strength: 2 mg/1
Pharmacologic classes: Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	76385-105		D	Discontinued by firm	2026-10-05
excluded package	package	76385-105	76385-105-01	D	Discontinued by firm	2026-10-05
excluded package	package	76385-105	76385-105-10	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 45 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76385-105-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76385-105-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76385-105-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76385-105-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76385-105-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76385-105-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76385-105-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76385-105-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76385-105-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76385-105-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76385-105-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76385-105-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76385-105-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76385-105-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76385-105-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76385-105-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76385-105-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76385-105-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76385-105-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76385-105-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76385-105-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76385-105-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76385-105-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76385-105-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	76385-105-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	76385-105-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	76385-105-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	76385-105-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	76385-105-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	76385-105-01	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090168-001	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28
A090168-002	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28
A090168-003	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A090168-001	AA
A090168-002	AA
A090168-003	AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090168-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2012-11-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090168-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2012-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090168-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2012-11-28	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090168-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090168-002	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090168-003	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090168-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090168-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090168-003	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090168-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090168-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090168-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090168-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090168-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090168-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090168-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090168-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090168-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090168-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090168-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090168-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090168-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090168-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090168-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090168-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090168-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090168-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090168-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090168-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090168-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090168-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090168-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090168-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090168-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090168-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090168-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090168-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090168-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090168-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090168-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090168-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090168-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090168-001	AA	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2961cf47-535c-c402-c24d-0a9130269674	Product name	3	20251121
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
3f930a8b-cc65-fba9-e4ca-58b6abcea16b	Product name	2	20220509

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
76385-105-01	2025-12-30	BENZTROPINE MESYLATE Tablets USP 0.5 mg, 1 mg and 2 mg Bayshore Pharmaceuticals LLC Rx only
76385-105-10	2025-12-30	BENZTROPINE MESYLATE Tablets USP 0.5 mg, 1 mg and 2 mg Bayshore Pharmaceuticals LLC Rx only
76385-105-01	2024-01-30	BENZTROPINE MESYLATE Tablets USP 0.5 mg, 1 mg and 2 mg Bayshore Pharmaceuticals LLC Rx only
76385-105-10	2024-01-30	BENZTROPINE MESYLATE Tablets USP 0.5 mg, 1 mg and 2 mg Bayshore Pharmaceuticals LLC Rx only

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZTROPINE MESYLATE	ACTIVE INGREDIENT	WMJ8TL7510	BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
BENZTROPINE MESYLATE	ACTIVE INGREDIENT	WMJ8TL7510	BENZTROPINE MESYLATE TABLET [BAYSHORE PHARMACEUTICALS, LLC]	1
BENZTROPINE	ACTIVE MOIETY	1NHL2J4X8K	BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
BENZTROPINE	ACTIVE MOIETY	1NHL2J4X8K	BENZTROPINE MESYLATE TABLET [BAYSHORE PHARMACEUTICALS, LLC]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BENZTROPINE MESYLATE TABLET [BAYSHORE PHARMACEUTICALS, LLC]	1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	BENZTROPINE MESYLATE TABLET [BAYSHORE PHARMACEUTICALS, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BENZTROPINE MESYLATE TABLET [BAYSHORE PHARMACEUTICALS, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	BENZTROPINE MESYLATE TABLET [BAYSHORE PHARMACEUTICALS, LLC]	1
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BENZTROPINE MESYLATE TABLET [BAYSHORE PHARMACEUTICALS, LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BENZTROPINE MESYLATE TABLET [BAYSHORE PHARMACEUTICALS, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BENZTROPINE MESYLATE TABLET [BAYSHORE PHARMACEUTICALS, LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76385-105	BENZTROPINE MESYLATE TABLET [BAYSHORE PHARMACEUTICALS LLC (NJ)]	7	Legacy NDC	20210128_298f140d-b4e4-4cc6-a304-b32eaba3f0b0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	REMEDYREPACK INC.	241479dd-91bf-455a-80a1-1bb2d1c8156d	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090168 application number: ANDA090168
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	REMEDYREPACK INC.	01688e6f-7b22-41bf-9a85-1c88d90f99b6	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090168 application number: ANDA090168
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	REMEDYREPACK INC.	7430b584-2812-4af5-994a-33dd1afed476	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090168 application number: ANDA090168
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	Leading Pharma, LLC	fe002ec4-07cb-41ca-a58c-33b3a8682101	2021-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090168 application number: ANDA090168
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	Aphena Pharma Solutions - Tennessee, LLC	f82c6455-f36b-49d7-881e-6601d513d846	2021-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090168 application number: ANDA090168
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	Proficient Rx LP	c1044563-2bd2-4f43-a951-25d083b1c679	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090168 application number: ANDA090168

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WMJ8TL7510	BENZTROPINE MESYLATE	132-17-2	BENZTROPINE MESYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
885219	benztropine mesylate 0.5 MG Oral Tablet	PSN	e653f9bc-40db-4048-bcf2-6fa46db85895	6
885213	benztropine mesylate 1 MG Oral Tablet	PSN	e653f9bc-40db-4048-bcf2-6fa46db85895	6
885209	benztropine mesylate 2 MG Oral Tablet	PSN	e653f9bc-40db-4048-bcf2-6fa46db85895	6
885219	benztropine mesylate 0.5 MG Oral Tablet	SCD	e653f9bc-40db-4048-bcf2-6fa46db85895	6
885213	benztropine mesylate 1 MG Oral Tablet	SCD	e653f9bc-40db-4048-bcf2-6fa46db85895	6
885209	benztropine mesylate 2 MG Oral Tablet	SCD	e653f9bc-40db-4048-bcf2-6fa46db85895	6
885209	benztropine mesylate 2 MG Oral Tablet	PSN	097c9f4b-2f5f-44e5-bf42-7ea93008e572	3
885209	benztropine mesylate 2 MG Oral Tablet	PSN	23b284e0-fbe6-4aa7-b8d1-e376eaff2555	3
885209	benztropine mesylate 2 MG Oral Tablet	SCD	097c9f4b-2f5f-44e5-bf42-7ea93008e572	3
885209	benztropine mesylate 2 MG Oral Tablet	SCD	23b284e0-fbe6-4aa7-b8d1-e376eaff2555	3
885219	benztropine mesylate 0.5 MG Oral Tablet	PSN	615c7f81-af4c-4194-9758-99b43a3d2e26	1
885213	benztropine mesylate 1 MG Oral Tablet	PSN	615c7f81-af4c-4194-9758-99b43a3d2e26	1
885209	benztropine mesylate 2 MG Oral Tablet	PSN	615c7f81-af4c-4194-9758-99b43a3d2e26	1
885219	benztropine mesylate 0.5 MG Oral Tablet	SCD	615c7f81-af4c-4194-9758-99b43a3d2e26	1
885213	benztropine mesylate 1 MG Oral Tablet	SCD	615c7f81-af4c-4194-9758-99b43a3d2e26	1
885209	benztropine mesylate 2 MG Oral Tablet	SCD	615c7f81-af4c-4194-9758-99b43a3d2e26	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76385-105-01	76385010501	100 TABLET in 1 BOTTLE, PLASTIC (76385-105-01)	100 tablet	2014-01-31	0000-00-00	No	No	Current
76385-105-10	76385010510	1000 TABLET in 1 BOTTLE, PLASTIC (76385-105-10)	1000 tablet	2014-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BENZTROPINE MESYLATE Tablets USP 0.5 mg, 1 mg and 2 mg Bayshore Pharmaceuticals LLC Rx only	Bayshore Pharmaceuticals LLC (NJ) \| Leading Pharma, LLC	2021-01-26	HUMAN PRESCRIPTION DRUG LABEL	7
BENZTROPINE MESYLATE Tablets USP 0.5 mg, 1 mg and 2 mg Bayshore Pharmaceuticals LLC Rx only	REMEDYREPACK INC.	2021-01-14	HUMAN PRESCRIPTION DRUG LABEL	5
BENZTROPINE MESYLATE Tablets USP 0.5 mg, 1 mg and 2 mg Bayshore Pharmaceuticals LLC Rx only	REMEDYREPACK INC.	2020-05-11	HUMAN PRESCRIPTION DRUG LABEL	4
BENZTROPINE MESYLATE Tablets USP 0.5 mg, 1 mg and 2 mg Bayshore Pharmaceuticals LLC Rx only	A-S Medication Solutions	2020-01-18	HUMAN PRESCRIPTION DRUG LABEL	3
BENZTROPINE MESYLATE Tablets USP 0.5 mg, 1 mg and 2 mg Bayshore Pharmaceuticals LLC Rx only	A-S Medication Solutions	2020-01-15	HUMAN PRESCRIPTION DRUG LABEL	3
Benztropine Mesylate	Marlex Pharmaceuticals Inc	2019-05-22	HUMAN PRESCRIPTION DRUG LABEL	6
BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg and 2 mg	State of Florida DOH Central Pharmacy	2014-12-07	HUMAN PRESCRIPTION DRUG LABEL	1